The Function of Gastrointestinal Tract During Pregnancy | NCT02577471

Studies
The Function of Gastrointestinal Tract During Pregnancy

NCT02577471

Sponsor

Kuopio University Hospital

Status

Completed

Last Update Posted

Oct 16, 2015Estimated

Enrollment

1,000Actual

Phase

Not provided

Conditions

Constipation

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Oct 14, 2015

First Submission Date that Met QC Criteria

Oct 15, 2015

First Posted Date

Oct 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this prospective study the function of gastrointestinal tract was assessed using constipation questionnaire (Rome criteria and bowel function index).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
During pregnancy		Pregnant ladies filled bowel function questionnaires
After delivery		ladies within three weeks of delivery filled bowel function questionnaires
Controls		Non pregnant ladies filled bowel function questionnaires

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bowel function	participants filled bowel function questionnaires	one week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent obtained
pregnancy, delivery
female non pregnant

Exclusion Criteria:

no informed consent
male

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

400 pregnant ladies, 400 ladies who had delivered within three weeks and 200 control ladies who were not pregnant

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kuopio University Hospital		Kuopio	Northern Savonia	70029	Finland

Condition Browse Module

MeSH Terms

ID	Term
D003248	Constipation

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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